Lyumjev (insulin lispro-aabc injection) / Eli Lilly - LARVOL DELTA

Monomeric Insulin Analog and Stabilizing Excipient Enabled Ultrafast Insulin Formulation. (PubMed, Adv Mater) - "In a porcine model of diabetes, monomeric HALQ exhibits significantly accelerated absorption and a shorter duration of action than the ultrarapid insulin aspart Fiasp...Addition of clinically used absorption enhancers further accelerates its pharmacokinetic profile, producing a faster time-to-peak and reduced exposure relative to ultrarapid insulin lispro Lyumjev in this animal model...These simulations suggest the potential utility of achieving a step-change in the speed of insulin therapy. These findings demonstrate that monomer-stabilizing excipients enable next-generation ultrafast insulin formulations with the potential to improve glycemic control in diabetes."

Journal • Diabetes • Metabolic Disorders

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Stanford University | Recruiting ➔ Completed | N=20 ➔ 10 | Trial completion date: Oct 2026 ➔ May 2026

Enrollment change • Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Treatment of Subcutaneous Insulin Resistance Syndrome with Co-Administered Subcutaneous Heparin and Insulin (ENDO 2026) - "She required Dexamethasone 4mg daily for treatment...Escalating subcutaneous insulin requirements and transition to Humulin R U-500 did not achieve glycemic control...On discharge, we recommended therapy with insulin lispro–aabc 32 units with meals which has been shown to aid insulin absorption through Treprostinil and citrate. Given the paucity of reported cases, our report emphasizes the need for awareness, timely diagnosis, and prompt initiation of appropriate therapy for Subcutaneous Insulin Resistance Syndrome."

Diabetes • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Lymphoma • Marginal Zone Lymphoma • Metabolic Disorders • Rare Diseases • Type 1 Diabetes Mellitus

Comparing Automated Lyumjev® Delivery with Carbohydrate Counting, Qualitative Meal-Size Estimation, and Fully Closed-Loop in Type 1 Diabetes: A Pilot, Randomized, Crossover Trial. (PubMed, Diabetes Technol Ther) - P2 | "In this pilot study, the AID system using Lyumjev simplified or alleviated carbohydrate counting without degrading glucose control more than 5%. Larger studies are warranted."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

KKB_2023_FActIn-T1DM: Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes (clinicaltrialsregister.eu) - P1 | N=20 | Completed | Sponsor: Katholisches Klinikum Bochum gGmbH | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Safety and Effectiveness of MiniMed™ 780G Advanced Hybrid Closed-Loop Use with Ultrarapid Insulin Lispro-AABC in Pediatric and Adult Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - "Similar to previous studies investigating automated URLi delivery, URLi use in the MiniMed™ 780G system was safe, and glycemic outcomes were favorable for pediatric and adult participants."

Journal • Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Ultrarapid Lispro (Lyumjev) Has an Improved Pharmacokinetic Profile for Exercise Compared With Humalog, Resulting in Less Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes on Open-Loop Continuous Subcutaneous Insulin Infusion. (PubMed, Diabetes Care) - "Using Lyumjev in conventional CSII pump therapy provides more effective BRRs prior to exercise compared with Humalog, with fewer hypoglycemic events in active adults with type 1 diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=11 | Completed | Sponsor: Mark D. DeBoer, MD, MSc., MCR | Recruiting ➔ Completed | N=20 ➔ 11

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

GLUCAGON-ENHANCED INSULIN ABSORPTION IMPROVES GLYCAEMIC CONTROL IN PIGS (ATTD 2026) - "This study investigated whether the vasodilating effect of nanogram doses of glucagon accelerates insulin absorption enough to improve postprandial glucose control. Pure Lyumjev (insulin) was compared with Lyumjev premixed with 50 ng of glucagon per unit of insulin... Premixing insulin with glucagon reduced postprandial glucose drop in pigs, suggesting that glucagon enhances insulin absorption. These preliminary results support further evaluation of this strategy in larger and longer studies to improve postprandial glucose control without the need for meal announcements."

Insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison chart: Some available insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500 (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Portal Diabetes, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500 (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Portal Diabetes, Inc.

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=150 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed | N=112 ➔ 150

Enrollment change • Trial completion • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Stanford University

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Nano-Amounts of Glucagon Premixed With Fast-Acting Insulin Lispro: Effect on Insulin Absorption in Pigs. (PubMed, Curr Ther Res Clin Exp) - "Nine pigs were included in the control groups; they received a subcutaneous injection of 10 U of insulin lispro (LyumjevⓇ or HumalogⓇ). A similar trend was observed when HumalogⓇ/glucagon was injected (306 mU×min/L vs 65 mU×min/L, SE = 125), although this difference did not reach statistical significance (P = 0.102) compared with the control groups. This series of proof-of-concept experiments in anesthetized pigs indicate that premixing nanogram doses of glucagon in fast-acting insulin lispro formulations may speed up the absorption of subcutaneously injected insulin."

Journal • Anesthesia

Efficacy of Ultra-rapid and Rapid-Acting Insulin Analogs in Hybrid and Advanced Automated Insulin Delivery Systems among People with Type 1 Diabetes—A Systematic Review and Meta-analysis of Randomized Controlled Trials (ADA 2025) - "Inclusion criteria were RCTs; T1D populations of any age; comparing URIAs (Fiasp® or Lyumjev®) with any type of RIAs; using any type of AID systems. URIAs safely improved glycemia and were comparable to RIAs among T1D people using AID systems. Despite outcomes demonstrating statistical significance, the clinical impact may be small, given the TIR improvement of 1.4% (registration ID: CRD42024578754)."

Metastases • Retrospective data • Review • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

MicroGlucag2: Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=30 | Suspended | Sponsor: St. Olavs Hospital | Not yet recruiting ➔ Suspended | Trial primary completion date: Jul 2025 ➔ Nov 2025

Trial primary completion date • Trial suspension • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR

New trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

MICRO-AMOUNTS OF GLUCAGON PREMIXED IN FAST-ACTING INSULIN (LYUMJEV®); EFFECT ON INSULIN ABSORPTION AND GLUCOSE CONSUMPTION (ATTD 2025) - "We expect to observe that premixing ng amounts of glucagon added to a fast-acting insulin speed up insulin absorption also in patients with T1D and enhances the effect on glucose metabolism. That will be a major achievement that potentially will benefit all patients with T1D. And it may make a fully automated artificial pancreas possible."

Anesthesia

FIRST CLINICAL REPORT OF THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM BOLUS CALCULATOR USE IN FREE LIVING ENVIRONMENT (ATTD 2025) - "The Lilly Tempo Smart Button enables Basaglar®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. Use of the IC was consistent across all meals and corrections.Conclusions The aggregate glucose data indicates increased usage of the IC over the 6-week period corresponds to greater trust in the IC recommendations, as a significant percentage of administered doses were within 10% of the IC's suggested dose. Aggregate data indicates meaningful improvement in glycemic outcomes with the Tempo Platform IC over this period."

Clinical • Diabetes • Metabolic Disorders

MicroGlucag2: Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: St. Olavs Hospital

New P1/2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus